Surgical Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 7, 2021 Changzhou Holymed Products Co., Ltd. Shan Shang Regulatory Correspondent 525 Changwu Road South Changzhou, Jiangsu 213167 China Re: K210524 Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 15, 2021 Received: April 20, 2021 Dear Shan Shang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III. PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210524 Device Name Surgical Mask Indications for Use (Describe) The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile. Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitter | Manufacturer Name and Address: | Changzhou Holymed Products Co., Ltd.<br>525 Changwu Road South<br>Wujin District, Changzhou<br>Jiangsu, China 213167 | |--------------------------------|----------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ms. Shan Shang | | Telephone Number: | +86 183 5120 0602 | | Email Address: | shan.shang@gogii.ca | 2. Device Name | Device Name: | Surgical Mask | |--------------|---------------| | Common Name: | Surgical Mask | Regulatory Information: | Classification Name: | Mask, Surgical | |----------------------|-----------------| | Regulation Number: | 21 CFR 878.4040 | | Product Code: | FXX | | Device Class: | Class II | #### 3. Predicate K160269 Level 3 Surgical Face Masks by San-M Package Co., Ltd. Particularly, the following model: | Model # | Style | |---------|----------| | EL30000 | Ear-loop | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol that resembles a plus sign with rounded edges, followed by the word "HOLYMED" in gray, block letters. The symbol is on the left side of the logo, and the word "HOLYMED" is on the right side. #### 4. Device Description The surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges. The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex. A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose. The surgical mask is intended to be a single-use disposable device, provided non-sterile. | Product # | Style | Color | |-----------|----------|-------| | HM-02-01 | Ear-loop | Blue | #### 5. Intended Use/ Indication for Use The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile. #### 6. Comparison to Predicate #### (a) Technological Characteristics Summarized in Table 1 below is the comparison of the technological characteristics between the proposed and the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol on the left and the word "HOLYMED" in gray on the right. The symbol is a stylized cross made up of rounded squares and a circle in the center. | Table 1 - Technological Characteristics Comparison | | | | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Description | Proposed Device | Predicate Device | Comparison | | 510(k) Number | K210524 | K160269 (EL30000) | N/A | | Manufacturer | Changzhou Holymed Products<br>Co., Ltd. | San-M Package Co., Ltd. | N/A | | Common Name | Surgical Mask | Surgical Mask | Identical | | Classification | Class II | Class II | Identical | | Product Code | FXX | FXX | Identical | | Intended Use | The surgical mask is intended<br>to be worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material. The<br>surgical mask is intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single-use, disposable device,<br>provided non-sterile. | The surgical face masks are<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>materials. These face masks<br>are intended for use in<br>infection control practices to<br>reduce the potential exposure<br>to blood and body fluids. This<br>is a single-use, disposable<br>device, provided non-sterile. | Identical | | Material Composition | | | | | Outer Cover | Polypropylene spunbonded | Polypropylene | Similar | | Middle Layer | Polypropylene melt-blown | 1. Polypropylene spunbond<br>2. Polypropylene meltblown | Similar | | Inner Facing | Polypropylene spunbonded | Polypropylene | Similar | | Nosepiece | Polyethylene laminated<br>aluminum | Polyethylene coated steel wire | Similar | | Ear-loop | Knitted polyester/ elastane | Polyester, polyurethane. Side<br>tapes: Polyester spunbond<br>(ear loops mask only) | Similar | | Colorant | Polypropylene masterbatch | Unknown | Similar | | Dimensions | | | | | Length | $95 \pm 3mm$ | $90 \pm 3 mm$ | Similar | | Width | $175 \pm 3mm$ | $175 \pm 5 mm$ | Similar | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol resembling a stylized plus sign or a network of interconnected nodes, followed by the word "HOLYMED" in gray, block letters. The symbol is on the left, and the text is on the right. | Design Features | Ear-loop | Ear-loop | Identical | |-----------------|------------------------|------------------------|-----------| | Color | Blue | White or blue | Similar | | Mask Style | Flat-pleated | Flat-pleated | Identical | | Sterility | Non-sterile | Non-sterile | Identical | | Use Frequency | Single-use, disposable | Single use, disposable | Identical | | ASTM 2100 Level | Level 3 | Level 3 | Identical | #### (b) Performance - (i) Clinical Test: Not applicable. - (ii) Non-Clinical Test: The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions posted on July 14, 2004. All samples met the performance acceptance criteria and performed as effective as the predicate device. Provided below in Table 2 is the summary of the non-clinical testing that was performed per specification of the standard and test methodology listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology. #### Table 2: Non-Clinical Performance Testing Table | Test<br>Methodology | Purpose | Acceptance Criteria | Results | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fluid Resistance<br>ASTM F1862 | Determine the<br>ability of the<br>mask's material<br>to resist<br>penetration of<br>blood and body<br>fluids. | Pass/fail basis at any<br>of three velocities<br>corresponding to the<br>range of human blood<br>pressure<br>Level 1 – 80 mmHg<br>Level 2 – 120 mmHg<br>Level 3 - 160 mmHg | Level 3<br>Passed at 160 mmHg.<br>All 3 lots tested passed with no<br>synthetic blood penetration<br>observed at 160 mmHg, under<br>the conditions of the test. | | Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | Determine the<br>ability of the<br>mask's material<br>to prevent<br>passage of<br>aerosolized<br>submicron<br>particulates. | Pass/fail basis<br>Level 1 – 95%<br>Level 2 – 98%<br>Level 3 – 98% | Level 3<br>Passed at > 99.9%<br>Average Filtration Efficiency:<br>AMSB-LOT202010007: >99.979%<br>AMSB-LOT202011002:<br>>99.9814%<br>AMSB-LOT202011005: >99.984% | | Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101-19<br> | Determine the<br>ability of the<br>mask's material<br>to prevent<br>passage of<br>aerosolized<br>bacteria.<br>Determine the<br>resistance of<br>the surgical<br>facemask to air<br>flowing through<br>the mask. | Pass/fail basis<br>Level 1 - 95%<br>Level 2 – 98%<br>Level 3 – 98%<br>Pass/fail basis<br>Level 1 – <5 mm<br>H2O/cm²<br>Level 2 – <6 mm<br>H2O/cm²<br>Level 3 – <6 mm<br>H2O/cm² | Level 3<br>Passed at ≥ 99.9%<br>All samples tested passed with a<br>filtration efficiency percentage of<br>at least 99.9%, under the<br>conditions of the test.<br>Level 1<br>Passed, < 5 mm H2O/cm².<br>AMSB-LOT202010007: ≤ 3.7 mm<br>H2O/cm2.<br>AMSB-LOT202011002: ≤ 3.7 mm<br>H2O/cm2.<br>AMSB-LOT202011005: ≤ 4.9 mm<br>H2O/cm2. | | Flammability<br>16 CFR Part 1610 | Determine the<br>ability of the<br>mask to resist<br>ignition to an<br>externally<br>applied ignition<br>source. | Pass/fail basis<br>Class 1, normal<br>flammability specified<br>in 16 CFR Part 1610. | Passed at Class 1<br>All samples tested achieved a<br>Class 1 flammability rating under<br>the conditions of the test. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue and white symbol that resembles a plus sign. The company name is written in gray, block letters. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue and white symbol that resembles a plus sign. The company name is in all caps and in a dark gray color. ## (c) Safety To address the safety risks from wearing of the surgical mask, biocompatibility tests were performed according to the standard ISO 10993 as referenced in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions posted on July 14, 2004. All samples met the test criteria and are as safe as the predicate device. Test results are summarized in Table 3 below. | Table 3: Summary of Biocompatibility Test Result and Comparison | | | | | | | | |-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------|--|--|--|--| | Test<br>Methodology | Purpose | Acceptance Criteria | Results | | | | | | Cytotoxicity<br>ISO 10993-5 | Determine the biological<br>response of mammalian<br>cells in-vitro | Non-cytotoxic | Under the conditions of<br>the study, non-<br>cytotoxicity effect | | | | | | Skin-irritation<br>ISO 10993-10 | Assess the potential of a<br>medical device and its<br>constituent materials to<br>produce skin irritation | Non-irritating | Under the conditions of<br>the study, non-irritation | | | | | | Sensitization<br>ISO 10993-10 | Assess the potential of a<br>medical device and its<br>constituent materials to<br>produce host sensitization | Non- sensitizing | Under the conditions of<br>the study, non-<br>sensitization | | | | | ### (d) Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K210524, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.